Cleared Traditional

LEUKO-TEST (K951101) - FDA 510(k) Clearance

Class I Immunology device.

K951101 · Techlab, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
45d
Days
Class 1
Risk

K951101 is an FDA 510(k) clearance for the LEUKO-TEST. Classified as Lactoferrin, Antigen, Antiserum, Control (product code DEG), Class I - General Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 24, 1995 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5570 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Techlab, Inc. devices

Submission Details

510(k) Number K951101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1995
Decision Date April 24, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 104d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DEG Lactoferrin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5570
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.